Trial Outcomes & Findings for High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery (NCT NCT00533949)

Last Updated: 2022-06-21

Results Overview

Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

544 participants

Primary outcome timeframe

From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Results posted on

2022-06-21

Participant Flow

Participant milestones

Participant milestones
Measure	60 Gy RT 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	74 Gy RT 74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	60 Gy RT + Cetuximab 60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin	74 Gy RT + Cetuximab 74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Overall Study STARTED	166	121	147	110
Overall Study COMPLETED	151	107	137	100
Overall Study NOT COMPLETED	15	14	10	10

Reasons for withdrawal

Reasons for withdrawal
Measure	60 Gy RT 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	74 Gy RT 74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	60 Gy RT + Cetuximab 60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin	74 Gy RT + Cetuximab 74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin
Overall Study Protocol Violation	12	12	9	9
Overall Study Withdrawal by Subject	3	2	1	1

Baseline Characteristics

High-Dose or Standard-Dose Radiation Therapy and Chemotherapy With or Without Cetuximab in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	60 Gy RT n=151 Participants 60 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	74 Gy RT n=107 Participants 74 Gy Radiation therapy with concurrent paclitaxel and carboplatin followed by consolidation paclitaxel and carboplatin	60 Gy RT + Cetuximab n=137 Participants 60 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin	74 Gy RT + Cetuximab n=100 Participants 74 Gy Radiation therapy with concurrent cetuximab, paclitaxel, and carboplatin followed by consolidation cetuximab, paclitaxel, and carboplatin	Total n=495 Participants Total of all reporting groups
Age, Continuous	64 years n=5 Participants	64 years n=7 Participants	64 years n=5 Participants	64 years n=4 Participants	64 years n=21 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	39 Participants n=7 Participants	60 Participants n=5 Participants	47 Participants n=4 Participants	200 Participants n=21 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	68 Participants n=7 Participants	77 Participants n=5 Participants	53 Participants n=4 Participants	295 Participants n=21 Participants

PRIMARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: Eligible patients who did not withdraw consent; patients enrolled while high dose arms open to accrual are included in the RT comparison, patients enrolled while cetuximab arms open to accrual are included in the cetuximab comparison. See "Limitations and Caveats".

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=217 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=207 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab n=237 Participants Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab n=228 Participants Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Overall Survival	28.7 months Interval 24.1 to 36.9	20.3 months Interval 17.7 to 25.0	25.0 months Interval 20.2 to 30.5	24.0 months Interval 19.8 to 28.6

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

A failure for progression-free survival (PFS) is the first occurrence of local or regional progression, distant metastases, or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a nontarget lesion, or the appearance of new lesions. Time is measured from the date of randomization to the date of first failure. Patients without failure are censored at the date of last follow-up.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=217 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=207 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab n=237 Participants Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab n=228 Participants Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Progression-free Survival	11.8 months Interval 10.2 to 14.3	9.8 months Interval 8.8 to 11.6	10.8 months Interval 9.8 to 12.3	10.7 months Interval 9.3 to 13.2

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

A failure for local-regional failure is the first occurrence of local or regional progression. Time is measured from the date of randomization to the date of first failure. Patients alive without local or regional failure at the time of last follow-up are censored. Patients who died without local or regional failure are considered as having competing risk at the time of death. Local-regional failure was estimated by the cumulative incidence method and 2 year estimates are reported.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=217 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=207 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab n=237 Participants Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab n=228 Participants Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Local-regional Failure (Reported as Two-year Estimates)	42.3 percentage of participants Interval 35.7 to 49.0	48.4 percentage of participants Interval 41.5 to 55.3	47.1 percentage of participants Interval 40.6 to 53.6	40.7 percentage of participants Interval 34.2 to 47.3

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.

Treatment-related esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=217 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=207 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 Esophagitis	7.4 percentage of participants Interval 4.3 to 11.7	20.8 percentage of participants Interval 15.5 to 26.9	—	—
Percentage of Participants With Grade 3-5 Esophagitis and Pneumonitis Adverse Events as Assessed by NCI Common Toxicity Criteria for Adverse Effects (CTCAE) v3.0 Pneumonitis	6.9 percentage of participants Interval 3.5 to 10.3	4.3 percentage of participants Interval 2.0 to 8.1	—	—

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: All eligible patients enrolled while the high dose arms were open, who did not withdraw consent.

Treatment-related adverse events other than esophagitis and pneumonitis were assessed graded using the CTCAE v3.0. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=217 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=207 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Percentage of Participants With Other Grade 3-5 Adverse Events as Assessed by NCI CTCAE v3.0	75.1 percentage of participants Interval 68.8 to 80.7	77.8 percentage of participants Interval 71.5 to 83.3	—	—

SECONDARY outcome

Timeframe: From start of protocol treatment to 24 months.

Population: Eligible patients who started study treatment and did not withdraw consent.

Deaths regardless of cause and occuring during or within 30 days of discontinuation of protocol treatment were evaluated.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=148 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=106 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab n=136 Participants Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab n=98 Participants Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Death During or Within 30 Days of Discontinuation of Protocol Treatment	2 percentage of participants Interval 0.0 to 4.3	3.8 percentage of participants Interval 0.1 to 7.4	8.8 percentage of participants Interval 4.1 to 13.6	4.1 percentage of participants Interval 0.2 to 8.0

SECONDARY outcome

Timeframe: At baseline and 3 months.

Population: Eligible patients who enrolled while the high dose arms were open, had baseline and 3 month assessments, and did not withdraw consent.

A decline of 2 points in the LCS from baseline to 3 months was considered a clinically meaningful change indicating a decline in quality of life. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=107 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=109 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Percentage of Patients With Decline From Baseline to 3 Months in the Lung Cancer Subscale (LCS) of the Functional Assessment of the Cancer Therapy Trial Outcome Index (FACT-TOI).	29.9 percentage of participants Interval 21.4 to 39.5	45.0 percentage of participants Interval 35.4 to 54.8	—	—

SECONDARY outcome

Timeframe: From randomization to 6 weeks after start of radiation therapy (6-10 weeks from randomization)

Population: Eligible patients enrolled while the high radiation therapy dose arms were open to accrual and who had at least 15 diary entries including one prior to start of radiation therapy and one during sixth week from start of radiation therapy.

Patients completed a swallowing diary prior to the start of treatment and then daily during treatment. Patients recorded a score to indicate problems with swallowing on that day (1-None, 2-Mild soreness only, 3-Can swallow solids with some difficulty, 4-Cannot swallow solids, 5-Cannot swallow liquids). These scores were then plotted across time and the area under the curve from baseline until the end of week 6 was calculated. A lower area under the curve indicates better swallowing ability. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation therapy.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=135 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=125 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Patient-reported Swallowing Score (Area Under the Curve)	79.5 Area under curve (score * days) Interval 59.5 to 99.0	78.0 Area under curve (score * days) Interval 55.5 to 97.0	—	—

SECONDARY outcome

Timeframe: From randomization to one year

Population: Eligible patients enrolled while the high radiation therapy dose arms were open to accrual, started treatment, and had baseline and at least one follow-up EQ5D VAS.

The visual analogue scale is a self-assessment of current health state, measured on a 20-cm scale ranging from 0 for the worst imaginable health state to 100 for best imaginable health state, marked at 10-point intervals. The area under the curve of each subject's EQ5D visual analog scale (VAS) response trajectory within 1 year was calculated. The EQ5D VAS utility was normalized by the baseline score. The trajectory included all available time points through one year. If a subject died within one year, the EQ5D VAS was reduced to 0 at the time of death. If subject was censored within one year, the EQ5D utility curve was truncated at the time of censoring. The scores were plotted across time and the area under the curve was calculated. A greater area under the curve indicates a better health state. Comparisons are only made between radiation therapy dosing levels because the cetuximab regimen was known to be safe in combination with radiation

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=135 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=118 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
EuroQoL (EQ5D) Visual Analog Scale (VAS) Through One Year (Area Under the Curve)	279.5 Score on a scale * months Interval 40.4 to 1852.4	265.4 Score on a scale * months Interval 55.9 to 76.9	—	—

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: Eligible patients with EGFR H-Score

EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. A local-regional event is the first development of progressive disease locally or regionally, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are reported.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=111 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=109 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group Two-year Survival rate	51.7 percentage of participants Interval 41.9 to 60.6	52.8 percentage of participants Interval 42.9 to 61.7	—	—
Overall Survival and Local-regional Failure by Epithelial Growth Factor Receptor (EGFR) Group Two-year Local-regional Failure rate	37.4 percentage of participants Interval 28.3 to 46.6	47.2 percentage of participants Interval 37.7 to 56.7	—	—

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: Eligible patients with EGFR H-Score

EGFR is a protein that is present on the surface of both normal cells and cancer cancer cells. EGFR H-Score is a measure of staining intensity ranging from 0 to 300 where a higher value indicates greater intensity of EGFR. Available tumor samples were evaluated for EGFR and given an H-Score. Patients were divided into two groups based on H-Score values dichotomized at 200. Worst toxicity as determined by adverse events was used as a measure of a patient's quality of life (QOL). Adverse events were graded using the Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grade refers to the severity of the AE. The CTCAE v3.0 assigns Grades 1 through 5 with unique clinical descriptions of severity for each AE based on this general guideline: Grade 1 Mild, Grade 2 Moderate, Grade 3 Severe, Grade 4 Life-threatening or disabling, Grade 5 Death related to AE. Highest grade (worst) adverse event (AE) per subject was counted.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=111 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT n=109 Participants Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Percentage of Patients With Grade 3+ Adverse Events by Epithelial Growth Factor Receptor (EGFR) Group	72.1 percentage of participants Interval 63.7 to 80.4	85.3 percentage of participants Interval 78.7 to 92.0	—	—

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: Eligible patients with GTV data

Gross tumor volume (GTV) is defined as the combined volume (cubic centimeters) of the primary tumor and clinically positive lymph nodes seen either on the planning computed tomography (CT) scan or the pretreatment positron emission tomography (PET) scan. Survival time is defined as time from randomization to date of death from any cause and is estimated by the Kaplan-Meier method. Patients last known to be alive are censored at the date of last contact. GTV was evaluated as a continuous variable therefore overall survival time is not summarized by GTV. "Prognostic" refers to the main effect and "predictive" refers to the interaction between GTV and treatment arm.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=356 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Prognostic and Predictive Effects of Gross Tumor Volume (GTV) on Overall Survival	25.0 months Interval 20.6 to 28.6	—	—	—

SECONDARY outcome

Timeframe: From randomization to last follow-up. Analysis occured after all patients were on study for 18 months. Maximum follow-up at time of analysis was 61.5 months.

Population: Eligible patients with PET SUV data at baseline.

Standardized uptake value (SUV) is a simple way of determining activity in PET imaging. It is a mathematically derived ratio of tissue radioactivity concentration at a point in time and the injected dose of radioactivity per kilogram of the patient's body weight. All event times are time from randomization to date of event or censoring. A survival event is death from any cause, patients without events are censored at the date of last contact, and survival rates are estimated by Kaplan-Meier method. Local-regional and distant metastasis events are the first development of progressive disease locally/regionally or distant metastasis, respectively, patients who do not have an event are censored at the date of death or last contact, and event rates are estimated by cumulative incidence. Two-year rates are presented. PET SUV was evaluated as a continuous variable therefore the outcome variables are not summarized by PET SUV.

Outcome measures

Outcome measures
Measure	Combined Patients Receiving 60 Gy RT n=444 Participants Combining patients from arms receiving 60 Gy radiation therapy (RT) (60 Gy RT and 60 Gy RT + Cetuximab)	Combined Patients Receiving 74 Gy RT Combining patients from arms receiving 74 Gy RT (74 Gy RT and 74 Gy RT + Cetuximab)	Combined Patients Receiving Cetuximab Combining patients from arms receiving Cetuximab (60 Gy RT + Cetuximab and 74 Gy RT + Cetuximab)	Combined Patients From Arms Receiving No Cetuximab Combining patients from arms receiving No Cetuximab (60 Gy RT and 74 Gy RT
Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure Time to Distant Metastasis	46.7 percentage of participants Interval 41.9 to 51.3	—	—	—
Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure Time to Local-Regional Failure	43.7 percentage of participants Interval 38.9 to 48.3	—	—	—
Prognostic Value of Pre-treatment Standardized Uptake Value (SUV) of Positron Emission Tomography (PET) Scan in Predicting Survival, Distant Metastasis, and Local-regional Failure Overall Survival	50.5 percentage of participants Interval 45.7 to 55.2	—	—	—

Adverse Events

60 Gy RT

Serious events: 60 serious events

Other events: 145 other events

Deaths: 0 deaths

74 Gy RT

Serious events: 49 serious events

Other events: 102 other events

Deaths: 0 deaths

60 Gy RT + Cetuximab

Serious events: 84 serious events

Other events: 129 other events

Deaths: 0 deaths

74 Gy RT + Cetuximab

Serious events: 57 serious events

Other events: 95 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Wendy Seiferheld, M.S.

NRG Oncology

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee PI's are required to abide by the sponsor's publication guidelines which require review by coauthors and subsequent review and approval by the sponsor.
Publication restrictions are in place

Restriction type: OTHER